AstraZeneca gives Phase 3 data on fulvestrant, says talking to U.S. regulators
AstraZeneca announced data from the Phase III FALCON trial demonstrating "superior" median progression-free survival for fulvestrant 500mg compared to anastrozole 1mg in the 1st line treatment of postmenopausal women with locally-advanced or metastatic breast cancer, who have not had prior hormonal treatment for hormone receptor positive breast cancer. The primary endpoint was PFS and the FALCON trial enrolled 462 patients. The results, announced at the 2016 European Society for Medical Oncology Congress, show that the median PFS was 2.8 months longer with fulvestrant than anastrozole. The median PFS was 16.6 months in the fulvestrant arm, compared with 13.8 months in the anastrozole arm. The safety and tolerability profile was in line with current experience with fulvestrant and anastrozole. The most commonly reported adverse events in the fulvestrant and anastrozole arms were arthralgia in 16.7% vs 10.3%, hot flashes in 11.4% vs 10.3%, and nausea in 10.5% vs 10.3%. "Given the FALCON trial results, AstraZeneca is now in discussions with US regulatory authorities about a planned regulatory submission for a potential label extension," the company noted.